Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections

Comparison of the Efficacy of Two Techniques for Sacroiliac Joint Injection: Ultrasound Guidance Versus Fluoroscopic Guidance

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02420041

Enrollment

Registered

2015-04-17

Start date

2012-10-31

Completion date

2014-03-31

Last updated

2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacroiliitis

Keywords

Sacroiliac Joint Injection, Fluoroscopy, Ultrasound

Brief summary

The purpose of this research project is to compare two different techniques for performing an injection of the sacroiliac joint. Although both techniques are safe and accurate, the goal of the study is to determine if one technique is better than the other with respect to improvement in a patient's pain, function, and his or her satisfaction. Additionally, the investigators want to determine if one technique is quicker and more efficient than the other.

Detailed description

Sacroiliac joint dysfunction is a source of low back pain that causes significant pain and disability. Injection of the sacroiliac joint with a local anesthetic/corticosteroid mixture has shown efficacy in treating this condition, when conservative therapy fails. The use of fluoroscopic guidance and anatomic landmarks are traditional methods for performing this injection; however, ultrasound imaging has recently been utilized for performing this procedure. Although studies exist that describe and validate the ultrasound technique, no studies exist that compare the techniques with respect to short-term and long-term outcomes. In this study, the primary objective is to determine if a difference exists between a fluoroscopic-guided technique and ultrasound-guided technique with respect to pain and function. A secondary objective is to compare the two techniques with respect to procedural characteristics.

Interventions

PROCEDUREActive comparator: Fluoroscopic Guided SIJ injection

* Needle entry point is in the lower one-third of the SIJ * Sterile preparation (with chlorhexidine) and draping and 3 mL of 1% lidocaine injected subcutaneously at site of needle entry * Under fluoroscopy guidance, Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle is inserted in a coaxial fashion into the SIJ * 1 mL of contrast (iohexol 300 mg/mL) is injected to outline the SIJ and to ensure no vascular uptake * Injection of 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine * Patient observed in recovery bay for 20 minutes and then discharged home

PROCEDUREUltrasound Guided Sacroiliac Joint Injection

* Sterile preparation (with chlorhexidine) and drape * Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer * 3 mL of 1% lidocaine is injected subcutaneously at site of needle entry * Under ultrasound guidance, a Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ. (0.5-2 mL of normal saline may be injected during needle insertion to locate tip of needle and to ensure solution does not spill out onto sacrum). * After using the Doppler function to identify any surrounding vessels (to avoid intravascular injection), 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine is injected. * Patient observed in recovery bay for 20 minutes and then discharged home

DEVICEHavel's Inc. EchoStim (facet tip) 21 Gauge 4 needle

DEVICESonoSite S-nerve

DEVICEiohexol

DRUGtriamcinolone/lidocaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Diagnosis of SIJ dysfunction by history and physical exam * History: Either low back pain or buttock pain * Exam: Either tenderness to palpation over the SIJ or a positive provocative maneuver (i.e., Patrick's, Gaenslen's, and/or Yeoman's test) 2. Failed a trial of conservative therapy which may included medications, physical therapy, or both 3. Age \> 18 4. Patient agrees to participate in study

Exclusion criteria

1. Coagulopathy 2. Renal or Hepatic Failure 3. Current Pregnancy or actively pursuing pregnancy 4. Known allergy to local anesthetic or steroids 5. Infection at site of needle placement or SIJ infection 6. Patient unable to consent himself or herself 7. Patient refusal 8. Prior surgical procedures involving the SIJ 9. Body Mass Index \> 35 kg/m2

Design outcomes

Primary

Measure	Time frame	Description
Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy	difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes	during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin
Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10	30 minutes pre-procedure minus baseline	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.
Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS	2 weeks post-procedure minus baseline	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.
Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS	3 months post-procedure minus baseline	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.

Secondary

Measure	Time frame	Description
Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale	2 weeks post-procedure	Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5	2 weeks post-procedure	1= very dissatisfied to 5=very satisfied.
Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale	3 months post-procedure	Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.
Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS	during/just before sacroiliac (SI) injection and 2 weeks post-procedure	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome. Score reported is reporting a difference/change between two time points.
Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS	during/just before sacroiliac (SI) injection and 3 months post-procedure	Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.Score reported is reporting a difference/change between two time points.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Fluoroscopic Guidance In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint. * Needle entry point is in the lower one-third of the SIJ * Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ	14
Ultrasound Guidance In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint. * Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer. * Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ.	14
Total	28

Baseline characteristics

Characteristic	Fluoroscopic Guidance	Ultrasound Guidance	Total
Age, Continuous	37 years STANDARD_DEVIATION 7.6175	34.07 years STANDARD_DEVIATION 8.2695	35.535 years STANDARD_DEVIATION 7.9435
Region of Enrollment United States	14 participants	14 participants	28 participants
Sex: Female, Male Female	6 Participants	5 Participants	11 Participants
Sex: Female, Male Male	8 Participants	9 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	5 / 14	3 / 14
serious Total, serious adverse events	0 / 14	0 / 14

Outcome results

Primary

Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS

Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.

Time frame: 2 weeks post-procedure minus baseline

Arm	Measure	Value (MEAN)
Fluoroscopic Guidance	Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS	-1 units on a scale
Ultrasound Guidance	Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS	-1.643 units on a scale

Primary

Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10

Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.

Time frame: 30 minutes pre-procedure minus baseline

Arm	Measure	Value (MEAN)
Fluoroscopic Guidance	Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10	-2.571 units on a scale
Ultrasound Guidance	Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10	-2.571 units on a scale

Primary

Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS

Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.

Time frame: 3 months post-procedure minus baseline

Population: numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study

Arm	Measure	Value (MEAN)
Fluoroscopic Guidance	Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS	-0.875 units on a scale
Ultrasound Guidance	Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS	-1.556 units on a scale

Primary

Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy

during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin

Time frame: difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes

Arm	Measure	Value (MEAN)
Fluoroscopic Guidance	Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy	9.471 minutes
Ultrasound Guidance	Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy	9.552 minutes

Secondary

Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS

Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome. Score reported is reporting a difference/change between two time points.

Time frame: during/just before sacroiliac (SI) injection and 2 weeks post-procedure